FDA Registration
Inactive
🇰🇷 South Korea
HYDROCHEM CO., LTD
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- HYDROCHEM CO., LTD
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 202-14, Gwahakdonji-Ro Sacheon-Myeon, Building B, 1st & 2nd Floor
- City
- Gangeung-Si Gangwon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K123085
Owner / Operator
- Firm Name
- Hydrochem Co., Ltd
- Operator Number
- 10095897
- Address
- 202-14, Gwahakdonji-Ro Sacheon-Myeon, Building B, 1st & 2nd Floor
- City
- Gangeung-Si
- State
- Gangwon
- Postal Code
- 25441
- Country
- KR
- Correspondent
- Soon Seop Shim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2026-05-19 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2026-05-19 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2026-05-18 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2026-05-19 |
| Surgical Mask With Antimicrobial/Antiviral Agent | OUK | Class 2 | General, Plastic Surgery | No | 2026-05-19 |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | NZJ | Class 2 | General Hospital | No | 2026-05-19 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2026-05-19 |
Proprietary Names
Travel Socks, Antimicrobial
O2 Respirator, Surgical w/ SOP
Face Mask Surgical w/ SOP, Techno Web
Dressing Wound Bed Sore w/ SOP
Face Mask Surgical, Antimicrobial w/ SOP
Mask, Oxygen, Fresh Patch w/ SOP
HC Portable Oxygen Concentrator w/ SOP
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)